Ex Parte Abdel-Monem et al - Page 7


                Appeal No. 2006-1226                                                                                Page 7                    
                Application No. 10/272,382                                                                                                    

                se, and therefore are anticipated by a prior art disclosure of any amount of the claimed                                      
                complex.  See, e.g., SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1335,                                           
                74 USPQ2d 1398, 1403 (Fed. Cir. 2005) (claim to “[c]rystalline paroxetine hydrochloride                                       
                hemihydrate” not limited to commercially significant amounts).                                                                
                         Appellants have not, for example, provided declaratory evidence to show that it                                      
                would have required undue experimentation to make a 1:1 neutral complex of glutamate                                          
                and zinc or copper.  Appellants have not shown that special conditions are required to                                        
                cause zinc or copper and glutamate in aqueous solution to form a 1:1 neutral complex,                                         
                nor have they shown that a skilled artisan who followed the Gramaccioli guidance would                                        
                not have produced such a complex.  While Appellants have pointed out the lack of                                              
                detailed experimental protocols in the Gramaccioli references, they have not provided                                         
                evidence to show that the lack of detail renders the references nonenabling.                                                  
                         For the same reason, we find unpersuasive Appellants’ argument that the                                              
                Gramaccioli references do not anticipate because “the author[s] did not provide any                                           
                independent evidence of the identity of the crystals or structure such as chemical or                                         
                elemental analysis or spectroscopic analysis.”  Appeal Brief, page 7; Abdel-Monem                                             
                declaration, ¶ 7.  A prior art reference is presumed to be enabling, and the burden is on                                     
                the party challenging enablement to prove it – in this context, by a preponderance of the                                     
                evidence.  See Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355, 65                                           
                USPQ2d 1385, 1416 (Fed. Cir. 2003).  The holding in Amgen was limited to prior art                                            
                patents, but the court noted that its holding, “by logical extension,” should apply to                                        
                nonpatent prior art as well.  Id. at 1355 n.22, 65 USPQ2d at 1416 n.22.  Appellants have                                      







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